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Table 4 Adverse events, safety population

From: Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials

Outcome Dabigatran 220 mg Enoxaparin 40 mg
(n = 2,156), n (%) (n = 2,157), n (%)
AEs during treatment   
Total with AEs 1,563 (72.5) 1,588 (73.6)
Serious AEs 146 (6.8) 141 (6.5)
AEs leading to treatment discontinuation 134 (6.2) 118 (5.5)
Drug-related AEs (investigator evaluation) 191 (8.9) 199 (9.2)
Wound infectionsa 16 (0.7) 21 (1.0)
Cardiovascular events   
 Myocardial infarction 2 (<0.1)b 6 (0.3)
 Ischemic stroke 0 1 (0.1)
ALT elevation; no. (%) patients   
 >3 x ULN anytime post baseline 71/2,101 (3.4)c 115/2,097 (5.5)c
 >3 x ULN plus bilirubin >2 x ULN during treatment period 3/2,092 (0.1)d 0/2,096
  1. Data are given as number (%) of patients except where indicated
  2. AE adverse event, ALT alanine aminotransferase, ULN upper limit of normal
  3. aIncludes wound hematomas, wound secretions, wound drainage and wound hemorrhage; bA further event in RE-NOVATE II occurred in the follow-up period; cNumber of patients with abnormality/total number of patients having tests; dA further patient in RE-NOVATE II had an elevation 3 months postsurgery while still in the follow-up period. None of the patients met the criteria for severe drug-induced hepatotoxicity [12]. One of these patients was diagnosed with acute cholangitis but a definitive diagnosis was not made in the other patient